Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19

A Phase 2, Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19

A phase 2, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib Maleate) in subjects hospitalized due to COVID-19

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: Placebo; Drug: STI-5656

Detailed Description

This is a phase 2, randomized, double-blind, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib Maleate) in subjects hospitalized due to COVID-19 in Brazil. Subjects are randomized 3:1 STI-5656 to placebo. Subjects receive either 100 mg of STI-5656 or placebo daily for 7 days. Standard of care will be maintained for all subjects throughout the study.

• Study Type: Interventional
• Enrollment (Actual): 396
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Santo André, SP, Brazil
      • Hospital e Maternidade Christóvão da Gama

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Confirmed positive for COVID-19 by RT-PCR assay or equivalent
• Subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board (IRB) or independent ethics committee (IEC) approved consent form prior to participating in any study related activity. However, if obtaining written informed consent is not possible, other procedures as provided in the March 27, 2020 (Updated on July 2, 2020) FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Question 10, may be used
• Able to swallow capsules
• Willing to follow contraception guidelines

Exclusion Criteria:

• Pregnant or breast feeding
• Suspected uncontrolled active bacterial, fungal, viral, or other infection other than COVID-19
• Treatment with a strong cytochrome p450 3A4 inhibitor or inducer within 7 days prior to Day 1
• Received anti-rejection or immunomodulatory drugs within 14 days prior to Day 1
• Concurrent participation in another clinical trial involving therapeutic interventions (observation studies are acceptable)
• Any condition that confounds the ability to interpret data from the study
• Any significant medical condition, laboratory abnormality, or psychiatric illness that would interfere with or prevent the subject from participating in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STI-5656; STI-5656 (abivertinib maleate) capsules administered orally 100 mg QD for 7 days, in addition to standard of care	Drug: STI-5656; STI-5656 (abivertinib maleate) is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor.; Other Names: AC0010; abivertinib maleate; avitinib; abivertinib
Placebo Comparator: Placebo; Placebo capsules administered orally daily for 7 days, in addition to standard of care	Drug: Placebo; Placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects discharged from hospital	Proportion of subjects whoa re alive and discharged from the hospital by Day 29	Randomization through Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (safety)	Types, frequencies, and severities of adverse events and their relationships to STI-5656, including serious adverse events	Randomization through study completion through Day 36
Time to hospital admission, treatment, and discharge	Time from onset of COVID-19 symptoms to hospital admission, time from hospitalization to start of treatment (D1), and time from D1 to hospital discharge	Randomization through study completion through Day 36
Number of days hospitalized	Number of days hospitalized from randomization through Day 36	Randomization to Day 36
Change in clinical status as assessed using a 0-8 ordinal scale	Change in clinical status as assessed using a 0-8 ordinal scale, where a lower score equals better outcome, at Days 3, 10, and 36	Randomization to Day 3, Day 10, and Day 36
Change in RT-PCR test results	Change in RT-PCR test results (or equivalent) at Days 3, 10, and 36	Randomization to Day 3, Day 10, and Day 36
Change in C-reactive protein levels	Change in C-reactive protein (CRP) levels at Day 3 and Day 10	Randomization to Day 3 and Day 10
AUC of STI-5656 (PK)	Area under the serum concentration-time curve (AUC) of STI-5656	Randomization through Day 8
Cmax of STI-5656 (PK)	Maximum observed serum concentration (Cmax) of STI-5656	Randomization through Day 8
t½ of STI-5656 (PK)	Apparent serum terminal elimination half life (t½) of STI-5656	Randomization through Day 8
Change in cytokine levels	Change in cytokine levels (including IL-6, TNF-a, IFNγ, IL1β) at Day 3 and Day 10	Randomization to Day 3 and Day 10
Tmax of STI-5656 (PK)	Time to Cmax (Tmax) of STI-5656	Randomization through Day 8

Collaborators and Investigators

• Sponsor: Sorrento Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Actual): August 23, 2021
• Study Completion (Actual): October 7, 2021

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: covid-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Abivertinib
• Other Study ID Numbers: BTK-COV-202BR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No